Elite Talent Hub LTD is a specialist in permanent staffing solutions for clients nationwide.
Our clients company, founded by an engineer and passionate craftsman, began a tradition of efficient, precise, and innovative manufacturing. Today, our clients help the world's largest orthopaedic manufacturers innovate, reduce costs, and improve quality, while also providing comprehensive design and manufacturing solutions to early-stage companies. As an agile and innovative partner, our clients use the latest machinery, technologies, and materials to deliver high-quality products at scale, reducing manufacturing costs.
Job Title: Quality Engineer
Reporting to: Associate Director of Quality
Job Description:
The scope of this role may not be limited to the contents listed on this job description.
Responsibilities:
- Investigate manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyse results, make recommendations, and develop reports.
- Collaborate with operations manager to develop and implement controls and improvements.
- Lead defect resolution, root cause investigation, and continuous improvement activities.
- Support FMEA and Inspection development to ensure that all failure modes in process have been identified and addressed.
- Coordinate quality data and reporting of KPIs to drive continuous improvement and feed into management review.
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
- Participates in internal audit and supplier audit programs for relevant ISO’s such as ISO 13485 and ISO 14001.
- Lead site change control activities.
- Investigates any Customer Complaints.
Requirements & Skills:
Required:
- Minimum degree in a science, quality, engineering or related discipline.
- Minimum 2 years industry experience.
- Strong written and oral communication skills.
- Experience working with medical device regulations.
Desired:
- Strong computer skills.
- Internal auditor courses for relevant ISO.